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Rheumatoid ArthritisPhase 3GO-FORWARDNCT00264550

An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Phase 3 study testing Golimumab 100 mg, Golimumab 50 mg and Methotrexate in people with Rheumatoid Arthritis, run by Centocor, Inc. at 50 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Golimumab 100 mg, Golimumab 50 mg and Methotrexate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
444 participants
Where
50 sitesin 12 countries
Study dates
Dec 2005to May 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to screening
  • Must have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a MTX dose of >=15 mg/week and <=25 mg/week and stable for at least 4 weeks prior to screening
  • Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a)C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or magnetic resonance imaging (MRI) prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening
  • If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent
  • Are considered eligible according to specified tuberculosis (TB) screening criteria

Who cannot join

  • Have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy
  • Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX, during the 4 weeks prior to the first administration of study agent
  • Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs (infliximab, etanercept, adalimumab)
  • Have had history of, or ongoing, chronic or recurrent infectious disease.
  • Have serious infection within 2 months prior to first administration of study agent
  • Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening

Trial locations and contacts

50 sites in 12 countries.

50 sites in 12 countries

United States13 sites

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Kansas City, Missouri

  • Study site

    Lincoln, Nebraska

  • Study site

    Mobile, Alabama

  • Study site

    Moline, Illinois

  • Study site

    Omaha, Nebraska

  • Study site

    Ormond Beach, Florida

  • Study site

    Palm Harbor, Florida

  • Study site

    Palo Alto, California

  • Study site

    Pasadena, California

  • Study site

    Richmond, Virginia

  • Study site

    St Louis, Missouri

  • Study site

    Upland, California

Other trials in United States

Canada6 sites

  • Study site

    Hamilton Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Sainte-Foy, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Victoria, British Columbia

Other trials in Canada

Germany6 sites

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Leipzig

  • Study site

    Rostock

Other trials in Germany

Argentina5 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Rosario

  • Study site

    S.M. de Tucuman

  • Study site

    San Miguel de Tucumán

Other trials in Argentina

Poland4 sites

  • Study site

    Elblag

  • Study site

    Kalisz

  • Study site

    Szczecin

  • Study site

    Warsaw

Other trials in Poland

South Korea4 sites

  • Study site

    Anyang

  • Study site

    Daegu

  • Study site

    Pusan

  • Study site

    Seoul

Other trials in South Korea

Australia3 sites

  • Study site

    Clayton

  • Study site

    Maroochydore

  • Study site

    Melbourne

Other trials in Australia

Chile3 sites

  • Study site

    Rancagua

  • Study site

    Santiago

  • Study site

    Temuco IX

Other trials in Chile

New Zealand3 sites

  • Study site

    Auckland

  • Study site

    Rotorua

  • Study site

    Timaru

Other trials in New Zealand

Hungary1 site

  • Study site

    Budepest

Other trials in Hungary

Mexico1 site

  • Study site

    Monterrey

Other trials in Mexico

Taiwan1 site

  • Study site

    Kaohsiung County

Other trials in Taiwan

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.

Read the detailed description

This is a randomized (treatment is assigned by chance), double-blind (neither the physician nor the patient is aware of the received treatment), placebo-controlled study of multiple subcutaneous (SC) administrations of golimumab at 2 doses as monotherapy or in combination with MTX in patients with active RA despite treatment with MTX. The duration of participation in the study for an individual patient will be upto 268 weeks. The patients will be randomly assigned in a 3:3:2:2 ratio to receive golimumab 50 mg or 100 mg or placebo injections under the skin every 4 weeks through week 20 and methotrexate or placebo capsules will be given in addition. At Week 24, all subjects will receive golimumab 50mg or 100mg injections, and golimumab continues for all groups for about 4 and a half more years. At Week 16 any patient in the study who meets criteria for < 20% improvement from baseline in both swollen and tender joint count will enter early escape in a double-blinded fashion. Treatment during the long-term extension will start at Week 52 and continue every 4 weeks thereafter for a total of approximately 5 years from the initial (Week 0) administration of study agent. Patients will return for scheduled follow-up visits generally every 12 weeks for a total length of follow-up of approximately 5 years from the first administration of the study drug.

Being tested
Golimumab 100 mg, Golimumab 50 mg, Methotrexate, Placebo injection, Placebo capsules
Keywords
Rheumatoid Arthritis, Golimumab, Methotrexate, Fully Human anti-TNFa monoclonal antibody, Simpony
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Golimumab 100 mgDrug

    Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.

  • Golimumab 50 mgDrug

    Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.

  • MethotrexateDrug

    Participants will receive methotrexate capsules weekly.

  • Placebo injectionDrug

    Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.

  • Placebo capsulesDrug

    Participants will receive placebo capsules weekly

Study groups in NCT00264550
Study groupRoleWhat they receive
Group 1: Placebo + MethotrexatePlacebo comparatorPlacebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Receives: Drug: Methotrexate; Drug: Placebo injection
Group 2: Golimumab 100 mg + PlaceboExperimentalGolimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7-10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Receives: Drug: Golimumab 100 mg; Drug: Placebo capsules
Group 3: Golimumab 50 mg + MethotrexateExperimentalGolimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Receives: Drug: Golimumab 50 mg; Drug: Methotrexate
Group 4: Golimumab 100 mg + MethotrexateExperimentalGolimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
Receives: Drug: Golimumab 100 mg; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14

    ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.

    Measured: Week 14

  2. Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24

    HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).

    Measured: Baseline (Week 0) and Week 24

Secondary outcomes (4)

  1. Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14

    DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response).

    Measured: Week 14

  2. Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24

    An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).

    Measured: Week 24

  3. Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14

    The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).

    Measured: Baseline (Week 0) and Week 14

  4. Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24

    The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.

    Measured: Baseline (Week 0) and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionSep 2007
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00264550
Sponsor's protocol ID
CR006343
Other IDs
C0524T06, 2004-003296-36, 2004
Acronym
GO-FORWARD
Status last verified
Apr 2014
First submitted
11 Dec 2005
Last updated
29 Apr 2014
Data monitoring committee
Yes

Publications

  • Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309.

    PubMed 30412238

  • George MD, Ostergaard M, Conaghan PG, Emery P, Baker DG, Baker JF. Obesity and rates of clinical remission and low MRI inflammation in rheumatoid arthritis. Ann Rheum Dis. 2017 Oct;76(10):1743-1746. doi: 10.1136/annrheumdis-2017-211569. Epub 2017 Jun 12.

    PubMed 28606966

  • Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec;43(12):2120-2130. doi: 10.3899/jrheum.160420. Epub 2016 Nov 1.

    PubMed 27803138

  • Mack ME, Hsia E, Aletaha D. Comparative Assessment of the Different American College of Rheumatology/European League Against Rheumatism Remission Definitions for Rheumatoid Arthritis for Their Use as Clinical Trial End Points. Arthritis Rheumatol. 2017 Mar;69(3):518-528. doi: 10.1002/art.39945.

    PubMed 27696724

  • Baker JF, Conaghan PG, Smolen JS, Aletaha D, Shults J, Emery P, Baker DG, Ostergaard M. Development and validation of modified disease activity scores in rheumatoid arthritis: superior correlation with magnetic resonance imaging-detected synovitis and radiographic progression. Arthritis Rheumatol. 2014 Apr;66(4):794-802. doi: 10.1002/art.38304.

    PubMed 24757132

  • Keystone EC, Genovese MC, Hall S, Miranda PC, Bae SC, Palmer W, Wu Z, Xu S, Hsia EC. Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: results through 2 years of the GO-FORWARD study extension. J Rheumatol. 2013 Jul;40(7):1097-103. doi: 10.3899/jrheum.120584. Epub 2013 May 15.

    PubMed 23678153

  • Genovese MC, Han C, Keystone EC, Hsia EC, Buchanan J, Gathany T, Murphy FT, Wu Z, Parasuraman S, Rahman MU. Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study. J Rheumatol. 2012 Jun;39(6):1185-91. doi: 10.3899/jrheum.111195. Epub 2012 Apr 15.

    PubMed 22505702

  • Visvanathan S, Rahman MU, Keystone E, Genovese M, Klareskog L, Hsia E, Mack M, Buchanan J, Elashoff M, Wagner C. Association of serum markers with improvement in clinical response measures after treatment with golimumab in patients with active rheumatoid arthritis despite receiving methotrexate: results from the GO-FORWARD study. Arthritis Res Ther. 2010;12(6):R211. doi: 10.1186/ar3188. Epub 2010 Nov 17.

    PubMed 21083889

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Golimumab 100 mg, Golimumab 50 mg and Methotrexate in people with Rheumatoid Arthritis, run by Centocor, Inc. at 50 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Canada, Germany, Argentina, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 (time frame: Week 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00264550, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.

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